Recruiting

PEER Interactive

Sponsor:

MYnd Analytics

Code:

NCT03625271

Conditions

Depression

Non-psychotic Diagnosis as Co-morbidity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

The PEER Report

Study Details

Brief summary:

This is a prospective, single-blinded, randomized, multicenter study to evaluate the utility, safety, and efficacy of using PEER Interactive - an EEG-based technology - to inform the prescription of medications to participants with a primary diagnosis of a depressive disorder, with or without comorbidity of non-psychotic behavioral disorders, versus treatment as usual.

Conditions

Depression

Non-psychotic Diagnosis as Co-morbidity

Study ID

NCT03625271

Start date

Jun 16, 2016

Status verified date

Jul, 2020

Completion date

Dec 1, 2021

Anticipated

Primary completion date

Jun 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male and female subjects between the ages of 18 - 65 years of age who speak and read English.
2. Participants able to provide written informed consent to participate in the study.
3. Participants with a primary diagnosis of a DSM-V depressive disorder, including subjects with comorbidity of a non-psychotic behavioral disorder.
4. Participants with comorbidity of mild traumatic brain injury (mTBI) are eligible for inclusion in this study. mTBI will be defined according to best clinical practice guidelines. The subject should have experienced no more than 30 minutes of loss of consciousness, less than a 24 hour alteration in consciousness or mental status, less than 24 hours of post-traumatic amnesia and a Glasgow Coma Scale (best available score in the first 24 hours) of 13 or greater.
5. Participants with comorbidity of post-traumatic stress disorder (PTSD) are eligible for inclusion in this study. A score of 45 or greater on the PTSD Checklist Military/Civilian (PCL-M/C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as a comorbid condition.
6. Able to stop specified medications, including drugs of abuse, for 5 half-lives of the medication(s). See Appendix B for a list of the five half-life time periods for these medications.

• The potential subject's primary care physician may be consulted to make these determinations.
7. Able to be washed out of specified medications within 14 days, i.e. 5 half-lives are not longer than 14 days (See Appendix B).
8. Participants will be selected from patients on the psychiatric inpatient ward, partially hospitalized patients, and psychiatric outpatients.
9. Ability to comply with the requirements of the study.

Exclusion Criteria:

1. Male and female subject less than 18 years old or greater than 65 years old
2. Participants who cannot provide written informed consent
3. Diagnosis of a psychotic disorder.
4. History of, or current, open head brain trauma.
5. Subjects with comorbidity of mild traumatic brain injury (mTBI) or traumatic brain injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24 hours) of less than 13.
6. Subjects who, in the opinion of the investigator, are unable to washout of specified medications in a period of 14 days or less..
7. History of: craniotomy, cerebral metastases, cerebrovascular accident; current diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features; or use of depot neuroleptics in last 12 months.
8. Clinically significant medical illness, including thyroid disorders, which cannot be remediated with medication, e.g. synthroid.
9. Participation in any other therapeutic drug study within 60 days preceding inclusion.
10. Known pregnancy and/or lactation, or intent to become pregnant during this study.
11. Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
12. Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
13. Candidates currently stable and considered to be at Maximum Medical Improvement (MMI) on current medications.
14. Participant has a positive urine drug screen.
15. Participant has active suicidal intent.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

All subjects will undergo same study procedures. Subjects in the Control Arm will receive treatment as usual by the prescribing clinician/investigator. The prescribing clinician/investigator will not receive the PEER Report of probable medication response for a control arm subject.

experimental: Experimental

All subjects will undergo same study procedures. Subjects in the Experimental Arm will receive treatment as usual by the prescribing clinician/investigator. However, the prescribing clinician/investigator will receive the PEER Report of probable medication response for an experimental arm subject. The report will provide additional data/information regarding probable medication response for an experimental arm subject to the prescriber .

Interventions

The PEER Report

PEER Interactive references a subject's QEEG to a normative and then symptomatic database. By comparing a given subject's QEEG to a database of QEEGs of subjects who have tried and responded to a specific medication, PEER provides useful information regarding the response of neurophysiologically similar subjects to a wide number of medications - providing clinicians with useful information as to medication outcomes before a medication regime is started. Clinicians have also reported that negative findings (in which neurophysiologically similar subjects reported resistant outcomes for certain medications) can be extremely useful in reducing trial and error. It has also been used to help select the medication that best matches the QEEG brainwave pattern.

Primary outcome measure

  • Quick Inventory of Depressive Symptomatology - Self Report 16 Item Questionnaire [ Time Frame: Day 0 through study completion, an average of 3 months. ]

Central Contacts and Locations

Central contacts

Locations

The Royal Mental Health Center

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Amelie Vezina, B.H.Sc., B.A Psych

(613) 722-6521Amelie.Vezina@theroyal.ca

Ashley Baddeley, B.A. (Hons.), M.Sc.

(613) 722-6521ashley.baddeley@theroyal.ca

More Information

Sponsor

MYnd Analytics

Last update posted

Jul 30, 2020

Last verified

Jul, 2020

Keywords

  • Electroencephalogram
  • data base
  • machine learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MYnd Analytics on 2020-07-30.